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AzTrials

HIV InfectionsPhase 3ANRS 143NCT01066962

Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

A Phase 3 study testing darunavir/ritonavir QD + raltegravir BID and darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 77 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
darunavir/ritonavir QD + raltegravir BID and darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
77 sitesin 15 countries
Study dates
Aug 2010to Oct 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with confirmed HIV infection
  • Age ≥ 18 years
  • Written informed consent
  • Male patient or non-pregnant, non-lactating female
  • No previous treatment with any antiretroviral drugs
  • HIV-1 RNA > 1000 copies/ml
Show all 27Show fewer
  • Indication to start an antiretroviral treatment as long as subject has also a CD4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening
  • No major IAS-USA mutations on genotypic testing at the screening visit or on any historical genotype, if available
  • Non-inclusion Criteria:
  • Woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
  • Pregnant or breastfeeding woman
  • Woman expecting to conceive during the study
  • HIV-2 co-infection
  • Creatinine clearance < 60 ml/mn (Cockcroft \& Gault equation), alkaline phosphatase, ASAT, or ALAT ≥ 5 ULN
  • Patient with significant impairment of hepatic function, defined as serum albumin < 2.8 g/dl or INR > 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding
  • CD4 > 500/mm3 at screening, except in case of symptomatic HIV disease (defined by conditions qualifying for CDC category B or C) or CD4 ≤ 500/mm3 on a sample taken within 3 months before screening.
  • Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening
  • Mycobacteriosis under treatment
  • Malignancy requiring chemotherapy or radiotherapy
  • Positive HBs Ag
  • HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment
  • Known hypersensitivity to one of the trial drugs or its excipients
  • Contraindicated concomitant treatment
  • Anticipated non-compliance with the protocol
  • Participation in another clinical trial with an on-going exclusion period at screening
  • Subject under legal guardianship or incapacitation
  • Subject, who in the opinion of the investigator, is unable to complete the study period

Who cannot join

None listed.

Trial locations and contacts

77 sites in 15 countries.

77 sites in 15 countries

France18 sites

  • Hôpital Pellegrin

    Bordeaux

  • Hôpital Saint André

    Bordeaux

  • Hôpital Henri Mondor

    Créteil

  • Hôpital du Bocage

    Dijon

  • Hôpital Pierre Zobda-Quitman

    Fort de France

  • CHD de la Roche sur Yon

    La Roche-sur-Yon

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Hôpital Gui de Chauliac

    Montpellier

  • Hôpital de l'Hôtel Dieu

    Nantes

  • Hôpital Bichat

    Paris

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris

  • Hôpital La Pitié Salpétrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • Hôpital Saint Louis

    Paris

  • Hôpital Pontchaillou

    Rennes

  • Hôpital Foch

    Suresnes

  • Hôpital Purpan

    Toulouse

  • Hôpital Gustave Dron

    Tourcoing

Other trials in France

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Clinic

    Barcelona

  • Hospital de la Santa Creu I Sant Pau.

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Germans Trias i Pujol

    Barcelona

  • Hospital Carlos III

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Gregorio Marañon

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario La Fe

    Valencia

Other trials in Spain

Italy9 sites

  • University of Brescia

    Brescia

  • Ospedale Santa Maria Annunziata

    Florence

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan

  • San Paolo Hospital

    Milan

  • Luigi Sacco Hospital

    Milan

  • Istituto Naziona e per le Malattie "Lazzaro Spallanzani"

    Rome

  • Sapienza Universita di Roma

    Rome

  • Torvergata University

    Rome

  • Ospedale "Amedeo di Savoia"

    Turin

Other trials in Italy

Germany8 sites

  • Gemeinschaftspraxis Jessen-Jessen-Stein

    Berlin

  • Med. Universitätsklinik I

    Bonn

  • Universitätsklinik Köln

    Cologne

  • Universitätsklinikum Essen

    Essen

  • Klinikum der Johann Wolfgang Goethe Universität

    Frankfurt

  • Asklepios-Klinik St. Georg

    Hamburg

  • ICH study centre

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

Other trials in Germany

United Kingdom8 sites

  • Royal Bournemouth Hospital

    Bournemouth

  • Southmead Hospital

    Bristol

  • Western General Hospital

    Edinburgh

  • Mortimer market centre

    London

  • Royal Free Hospital

    London

  • Saint Mary's hospital

    London

  • Saint Stephen's Centre

    London

  • Saint Thomas hospital

    London

Other trials in United Kingdom

Belgium3 sites

  • ITZ Antwerpen

    Antwerp

  • CHU Saint Pierre

    Brussels

  • UZ Gent

    Ghent

Other trials in Belgium

Greece3 sites

  • Attikon University Hospital

    Athens

  • Evaggelismos General Hospital

    Athens

  • Laikon General Hospital

    Athens

Other trials in Greece

Netherlands3 sites

  • AMC

    Amsterdam

  • Jan van Goyen Medical Center

    Amsterdam

  • Rijnstate Hospital

    Arnhem

Other trials in Netherlands

Portugal3 sites

  • Hospital de Curry Cabral

    Lisbon

  • Hospital Santa Maria

    Lisbon

  • Hospital de Joaquim Urbano

    Porto

Other trials in Portugal

Sweden3 sites

  • Sahlgrenska hospital

    Gothenburg

  • Karolinska hospital

    Stockholm

  • Venhälsan hospital

    Stockholm

Other trials in Sweden

Austria2 sites

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna

  • Otto Wagner Spital mit Pflegezentrum

    Vienna

Other trials in Austria

Denmark2 sites

  • Rigshospitalet

    Copenhagen

  • Hvidovre Hospital

    Hvidovre

Other trials in Denmark

Ireland2 sites

  • Mater Misericordiae

    Dublin

  • St James's Hospital

    Dublin

Other trials in Ireland

Hungary1 site

  • Saint Laszlo Hospital

    Budapest

Other trials in Hungary

Poland1 site

  • Hospital of Infectious Diseases of Warsaw

    Warsaw

Other trials in Poland

About this study

Official title: An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

Conditions
HIV Infections
Being tested
darunavir/ritonavir QD + raltegravir BID, darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
Keywords
HIV-infected antiretroviral naïve subjects
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • darunavir/ritonavir QD + raltegravir BIDDrug

    darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)

    ritonavir 100 mg, 1 tablet once daily (QD)

    raltegravir 400 mg, 1 tablet twice daily (BID)

  • darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)Drug

    darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)

    ritonavir 100 mg, 1 tablet once daily (QD)

    tenofovir/emtricitabine 245/200 mg, fixed dose combination, 1 tablet once daily (QD)

Study groups in NCT01066962
Study groupRoleWhat they receive
darunavir/r + tenofovir/emtricitabineActive comparatorNot described
Receives: Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
darunavir/r + raltegravirExperimentalNot described
Receives: Drug: darunavir/ritonavir QD + raltegravir BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components

    Measured: minimum 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01066962
Sponsor's protocol ID
2009-015113-44
Other IDs
2009-015113-44, 2009
Acronym
ANRS 143
Status last verified
Nov 2013
First submitted
9 Feb 2010
Last updated
6 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Esteban-Cantos A, Rodriguez-Centeno J, Barruz P, Alejos B, Saiz-Medrano G, Nevado J, Martin A, Gaya F, De Miguel R, Bernardino JI, Montejano R, Mena-Garay B, Cadinanos J, Florence E, Mulcahy F, Banhegyi D, Antinori A, Pozniak A, Wallet C, Raffi F, Rodes B, Arribas JR; NEAT001/ANRS143 Study Group. Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2021 Apr;8(4):e197-e205. doi: 10.1016/S2352-3018(21)00006-0.

    PubMed 33794182

  • Ammassari A, Stohr W, Antinori A, Molina JM, Schwimmer C, Domingo P, Thalme A, Di Pietro M, Wallet C, Pozniak A, Richert L, Raffi F; NEAT001/ANRS143 Trial Study Group. Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):481-490. doi: 10.1097/QAI.0000000000001834.

    PubMed 30365452

  • Bernardino JI, Mocroft A, Mallon PW, Wallet C, Gerstoft J, Russell C, Reiss P, Katlama C, De Wit S, Richert L, Babiker A, Buno A, Castagna A, Girard PM, Chene G, Raffi F, Arribas JR; NEAT001/ANRS143 Study Group. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015 Nov;2(11):e464-73. doi: 10.1016/S2352-3018(15)00181-2. Epub 2015 Sep 30.

    PubMed 26520926

  • Raffi F, Babiker AG, Richert L, Molina JM, George EC, Antinori A, Arribas JR, Grarup J, Hudson F, Schwimmer C, Saillard J, Wallet C, Jansson PO, Allavena C, Van Leeuwen R, Delfraissy JF, Vella S, Chene G, Pozniak A; NEAT001/ANRS143 Study Group. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.

    PubMed 25103176

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing darunavir/ritonavir QD + raltegravir BID and darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 77 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in France, Spain, Italy, Germany, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components (time frame: minimum 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01066962, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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